WO2021160666A1 - Système de traitement de plaies - Google Patents

Système de traitement de plaies Download PDF

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Publication number
WO2021160666A1
WO2021160666A1 PCT/EP2021/053202 EP2021053202W WO2021160666A1 WO 2021160666 A1 WO2021160666 A1 WO 2021160666A1 EP 2021053202 W EP2021053202 W EP 2021053202W WO 2021160666 A1 WO2021160666 A1 WO 2021160666A1
Authority
WO
WIPO (PCT)
Prior art keywords
drainage
layer
arrangement according
wound treatment
treatment arrangement
Prior art date
Application number
PCT/EP2021/053202
Other languages
German (de)
English (en)
Original Assignee
Lohmann & Rauscher Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lohmann & Rauscher Gmbh filed Critical Lohmann & Rauscher Gmbh
Priority to EP21705145.7A priority Critical patent/EP4103119A1/fr
Publication of WO2021160666A1 publication Critical patent/WO2021160666A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/05—Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]

Definitions

  • the invention relates to a wound treatment arrangement with a drainage device designed to drain fluids, such as liquids, in particular wound secretions and / or interstitial edema, and / or gases from a human or animal body, in particular from a wound.
  • fluids such as liquids, in particular wound secretions and / or interstitial edema, and / or gases from a human or animal body, in particular from a wound.
  • Such wound treatment arrangements are used in particular in the context of superficial, intra-abdominal, intrathoracic and / or intracorporeal negative pressure therapy.
  • the drainage device can be arranged between the wound and an occlusive film cover.
  • a negative pressure can be generated with the aid of an opening in the occlusive film cover and / or a drainage tube attached to the drainage device and / or an open-pored drainage material in fluid-conducting contact with the surface of the drainage device.
  • the wound is cleaned, during which the wound secretion is sucked off, the interstitial edema is reduced and the blood circulation is improved.
  • the object of the invention is to provide a wound treatment arrangement with which a satisfactory therapeutic success can be promoted.
  • the drainage device has a multilayer composite structure with two opposing, at least partially fluid-permeable, preferably approximately parallel to each other, boundary surfaces of which one is at least partially from one of a boundary layer between two adjacent drainage layers facing away from the first outer boundary surface of a first drainage layer with a first surface quality and the other at least partially from a boundary surface facing away from a boundary layer between two adjacent drainage layers of a second drainage layer with a different from the first Surface texture differentiating second surface texture is formed, wherein the drainage layers are preferably connected to one another in a fluid-conducting manner.
  • the invention is based on the knowledge that negative pressure therapy can make different demands on the drainage device even when treating only one wound, the failure of which results in only unsatisfactory healing. Furthermore, the invention is based on the knowledge that different wounds can make different demands on the drainage device in the context of negative pressure therapy, these demands also being able to change in the course of negative pressure therapy itself.
  • inventive further development of known wound treatment arrangements with a drainage device having a multilayer composite structure allows different material properties to be combined in the drainage device, which can be used therapeutically in negative pressure therapy and the disadvantages of a drainage device which has only one of the properties are eliminated.
  • the invention can be used in particular in superficial, intra-abdominal, intrathoracic and / or intracorporeal negative pressure therapy.
  • the drainage device provided according to the invention with a multilayer composite structure enables differentiated negative pressure therapy and eliminates disadvantages due to the use of individual materials.
  • the drainage device has only two drainage layers, so that the boundary layer facing away from the boundary surfaces is formed between the two drainage layers, which are connected to one another in a fluid-conducting manner.
  • the drainage layers can be connected by gluing, welding, sewing, laser welding or other connection techniques. It is essential that the connection of the drainage layers maintains fluid-conducting contact between the drainage layers.
  • the fluid-conducting contact between the drainage layers can be achieved through the open-pore fluid-conducting properties of the drainage layer and the surface of the drainage layers.
  • the fluid-conducting contact between the layers can also be established through separate fluid-conducting connections, openings in the surface of the layers, fluid-conducting communicating channels.
  • the first drainage layer can have an open-pore foam, in particular polyurethane foam.
  • open-pored includes a structure in which at least some pores of the foam are connected to one another in a fluid-conducting manner.
  • the thickness of the first drainage layer in a thickness direction extending perpendicular to the first outer delimiting surface can be imm or more, in particular 2 mm or more, particularly preferably 10 mm or more and / or 30 mm or less.
  • the total thickness of the The drainage device is preferably 1.5 mm or more, preferably 5 mm or more, in particular 15 mm or more and / or 50 mm or less, preferably 40 mm or less, in particular 35 mm or less.
  • the first outer boundary surface formed by the open-cell foam, in particular polyurethane foam has the properties of a sponge, in particular a polyurethane sponge.
  • a drainage unit equipped in the surface after application of a negative pressure, wound debridement, high adhesion to tissue, granulation of wound surfaces, increased blood flow and an erosive suction pattern corresponding to the sponge surface can be used via this first boundary surface in direct contact with the wound surface and in direct contact Generate standing body tissue in the course of negative pressure therapy.
  • the second drainage layer also has an open-pore foam, the properties of which differ from the properties of the open-pore foam of the first drainage layer
  • the second drainage layer of the multilayer composite structure used as a drainage device in the context of the invention can have a single or multilayer drainage film, wherein the second outer boundary surface can have a film layer penetrated by a plurality of perforation openings.
  • the second drainage layer consists of a single-layer perforated film.
  • the second drainage layer has at least two film layers, between which a drainage space is formed and each of which has a plurality of perforation openings which open into the drainage space.
  • the second outer boundary surface is formed by a first perforated film layer, while the boundary layer to the adjacent drainage layer is formed by the second film layer facing away from the second boundary surface, which is also perforated and has a fluid-conducting connection with the adjacent drainage layer, in particular the first drainage layer.
  • Suitable multilayer drainage films are specified in WO 2010/124844. Similar to the drainage films described in this document, the second drainage layer of a drainage device of a wound treatment arrangement according to the invention can also be designed in such a way that at least one perforation of a film layer extends through one of this film layer in the direction of the opposite inner boundary surface of the other film layer and one in forms the channel opening into the drainage space, the channel wall of which is preferably made in one piece with the film layer.
  • the cross-sectional area of the channel can be perpendicular to the Reduce the depth direction extending plane, starting from the first film layer in the direction of the opposite other delimiting surface, in particular to obtain a capillary action that promotes the entry of body fluid into the drainage space.
  • At least one film layer has a plurality of perforation openings, preferably arranged in a grid shape, the distance between adjacent openings being 15 mm or less, preferably 5 mm or less, in particular 3 mm or less.
  • the mouths of the openings arranged in one film layer in a projection along the depth direction can be arranged between the mouths of the perforation openings arranged in the other film layer.
  • the individual film layers can be connected to one another via punctiform fastening areas that are preferably designed in a grid arrangement. These fastening areas can be formed by a material bridge connecting the opposing boundary surfaces of the film layers.
  • At least one perforation opening has an area of 0.01 mm 2 or more and / or 1 mm 2 or less in a plane extending parallel to the second outer boundary surface .
  • the second outer boundary surface formed by the drainage film has the properties of a film. Under negative pressure, it develops a flat drainage effect, produces only slight adhesion to the wound and body tissue and is therefore particularly suitable for placing on surface-sensitive organs such as the intestine, peritoneum, pleura, and vessels. When the negative pressure is applied, a suction pattern corresponding to the pattern of the perforation openings is generated on the wound surface and in the tissue that is in contact.
  • both the first drainage layer and the second drainage layer are designed as single or multi-layer films, the properties of the films differing from one another.
  • the negative pressure therapy can be carried out using a drainage device with a multilayer composite structure within the scope of the invention according to the special therapeutic requirements and treated individually.
  • it is selected during the treatment which of the boundary surfaces of the multilayer composite structure is to have direct suction contact with the wound. If, for example, a wound is to be debrided, then the first outer boundary surface of the multilayer composite structure is brought into contact with the wound, which, when using a coarse-pored polyurethane foam, is characterized by strongly debriding and adhesive properties. If the wound is largely conditioned and cleaned, the second outer boundary surface, which is the case when using an open-pored double-layer drainage film has a suction-exerting but not so strongly adhering and debriding surface, brought into contact with the wound.
  • the wound is closed with an occlusion film over the drainage device placed therein. Then, for example, suction can be applied to the wound using a suction adapter.
  • the wound can also be closed with a film with open pores on one side.
  • the wound can also be closed with a transparent negative pressure bandage or a negative pressure plaster, which is connected to a negative pressure generating system in a fluid-conducting manner.
  • the second outer boundary surface that is to say the film side of the drainage device in the form of the multilayer composite structure, is preferably placed on the intra-abdominal organs. Due to the lower adhesion to the tissue, the risk of iatrogenic injuries to the tissue is reduced.
  • the drainage device used within the scope of the invention in the form of a multilayer composite structure can also be rolled up or folded in order, for example, to drain an intra-abdominal region in a more targeted manner.
  • the drainage device can be cut and / or divided.
  • it can be perforated so that a division can be made to obtain predetermined shapes and / or sizes, possibly by pulling. In this way, strips, rectangles, round, elliptical and / or spiral shapes can be obtained. This can make the placement easier, depending on the spatial conditions.
  • the individual parts can be brought into direct contact. Additionally or alternatively, the suction can be exerted via bridging elements such as open-pore film elements, polyurethane foams, drains or the like.
  • the second outer boundary surface that is to say the film side of the drainage device, is again placed on the pulmonary.
  • the first outer boundary surface that is to say the outer boundary surface formed by the open-pore foam, which leads, for example, to debridement of the pleura, can lie.
  • a drainage device can be constructed in which either only a polyurethane foam delimitation surface or a foil delimitation surface is provided on the outside, depending on the local requirements of the wound to be treated.
  • perforation of the drainage device can be useful for the purpose of facilitating division.
  • This embodiment of the invention creates a surface area on the second outer boundary surface in the area of the perforation hole or holes which has the properties of the other drainage layer, in particular the layer formed from an open-cell foam, in particular polyurethane foam. If a negative pressure is applied to this side, i.e. to the drainage layer formed by the open-pored foam, a suction effect on the wound, which is the first drainage layer, arises in the area of the second outer boundary surface, i.e. in the area of the second drainage layer equipped with the perforation holes is equivalent to. As a result, different surface-mediated suction effects are exerted on the wound. The suction behavior and also the suction strength exerted can hereby be designed irregularly on the surface facing the wound.
  • the above-described equipment of a boundary surface with perforation holes can be made in any material combination of the layered structure of the drainage unit.
  • a polyurethane foam can also be provided with perforation holes and the second drainage layer, which is closed, can consist of a film. This embodiment has the advantage that an additional granulation stimulus can be exerted on a wound due to the different thickness of the foam.
  • This structure can also be selected in the case of a layer structure with two polyurethane layers with different pore sizes.
  • At least one perforation hole has an opening area in a plane of 10 mm 2 or more, in particular 25 mm 2 or more and / or 1,000 mm 2 or less, in particular 400 mm 2 or less.
  • the second drainage layer can have two or more perforation holes with different opening areas and / or shapes.
  • the perforation holes can be circular, be elliptical and / or polygonal. They can also have other configurations.
  • the perforation holes can be formed in a regular grid structure, in an irregular structure, of the same size or of different sizes.
  • the second drainage layer has a plurality of perforation holes and the mutually facing edges of at least two perforation holes, in particular all perforation holes, have a distance of 1 mm or more, preferably 5 mm or more, wherein the distance can expediently be 100 mm or less, in particular 50 mm or less.
  • a wound treatment arrangement according to the invention can have an occlusion film for producing a closed wound space containing the drainage device.
  • the occlusion foil can be applied independently of the drainage device, so that the variability of the wound care arrangement according to the invention is not impaired.
  • the wound area can also be occluded with a film that is open-pored on one side.
  • the wound treatment arrangement according to the invention is expediently used in the context of negative pressure therapy.
  • the wound care arrangement according to the invention preferably has a suction device for generating a negative pressure in the region of at least one outer boundary surface of the drainage device.
  • the suction device can have a drainage hose connected in a fluid-conducting manner to the drainage device, in particular the first drainage layer, which on the other hand is connected to a vacuum source, such as a pump or a vacuum reservoir.
  • the suction can also be provided with another drainage device through direct surface contact.
  • the drainage device is wound up with respect to a winding axis running parallel to an outer delimiting surface.
  • the drainage device of wound care arrangements according to the invention expediently has a web-like course, it being possible for the drainage device to be rectangular with a side length of 1 to 50 cm.
  • the second drainage layer protrudes over the first drainage layer in the region of its edge at least in sections in a direction running parallel to the second outer delimiting surface.
  • the invention also relates to the use of a drainage device with a multilayer composite structure for producing a wound treatment arrangement according to the invention.
  • the first drainage layer can be connected to a drainage hose and / or the drainage device can be connected to a Drainage tube, an occlusive film, a one-sided open-pore film and / or a vacuum source can be combined to form a kit.
  • Fig. 1 is a side view of a for producing one according to the invention
  • Drainage device that can be used in a wound care arrangement according to a first embodiment of the invention
  • Fig. 2 is a side view of a for producing one according to the invention
  • FIG. 3 shows a perspective illustration of a drainage device suitable for producing a wound care arrangement according to the invention in accordance with a third embodiment of the invention
  • FIG. 4 shows a drainage device suitable for producing a wound care arrangement according to the invention according to a fourth embodiment of the invention
  • FIG. 5 shows a sectional illustration of the drainage device according to FIG. 4,
  • FIG. 6 shows a perspective illustration of a drainage device suitable for producing a wound care arrangement according to the invention in accordance with a fifth embodiment of the invention
  • FIG. 7 shows a sectional illustration of the drainage device according to FIG. 6,
  • FIG. 8 shows a further sectional illustration of the drainage device according to FIG. 6, and
  • FIG. 9 shows a drainage device suitable for producing a wound care arrangement according to the invention, according to a sixth embodiment of the invention.
  • the drainage device shown in Fig. 1 is formed in the form of a two-layer basic structure. It has a first drainage layer 10 formed by an open-pored polyurethane foam and a second drainage layer 20 formed by an open-pored film.
  • the second drainage layer 20 can be designed as a double-layer, open-pore film, as described in WO 2010/124844. It can also have a single layer.
  • the first drainage layer 10 is connected to the second drainage layer 20 in a fluid-conducting manner.
  • suction or negative pressure can also be generated in the area of the outer boundary surface 22 of the second drainage layer 20 facing away from the first drainage layer 10, as well as by applying a negative pressure in the area of the second drainage layer 20 in the area of the boundary surface 12 of the first drainage layer 10 facing away from the second drainage layer Vacuum or suction can be generated.
  • the embodiment of the invention shown in FIG. 2 differs from the embodiment shown in FIG. 1 essentially in that the edges of the second drainage layer 20 protrude beyond the edges of the first drainage layer 10. What is achieved thereby is that the delimitation surface 24 of the second drainage layer 20 facing away from the second delimitation surface 22 is designed to be exposed in the region of the protruding edges and is not covered by the first drainage layer 10.
  • the embodiment of the invention shown in FIG. 3 essentially differs from the embodiments explained with reference to FIGS. 1 and 2 in that the second drainage layer 20 is penetrated by perforation holes 26 through which the first drainage layer 10 is accessible. In this way it is achieved that in the area of the perforation holes a direct contact between the first drainage layer 10 and a wound on which the second drainage layer 20 rests is produced and a suction pattern corresponding to the perforation holes can be produced in the area of the wound. If the first drainage layer 10 is in the form of an open-pored polyurethane foam, polyurethane foam islands are created in the area of the perforation holes 26 with which, on the one hand, debridement and, on the other hand, an increased suction effect can be achieved.
  • FIG. 4 essentially differs from the embodiment explained with reference to FIG. 3 in that perforation holes 26, 26 ‘, 26 ′′ of different sizes are provided in the second drainage layer 20. This helps to create a desired suction pattern in the area of the wound.
  • the drainage device designed as a multilayer composite structure is wound into a multilayer roll via a winding axis running parallel to an outer boundary surface of the drainage layers, the second outer boundary surface 22 formed by the drainage film being the outside of the winding forms.
  • FIG. 9 corresponds essentially to the embodiment explained with reference to FIGS. 6 to 8, the winding of this Embodiment is designed so that the first outer boundary surface of the drainage device formed by the open-pore polyurethane foam forms the outside of the roll.
  • the invention is not restricted to the embodiments explained with reference to the drawing. Rather, embodiments are also intended in which the second drainage layer is formed by a single-layer film.
  • the perforation holes can also have an elliptical, oval or polygonal design, deviating from the circular shape.
  • the drainage device can be assigned a drainage tube which can be connected to the second drainage layer via a port and / or inserted into the first drainage layer. Two, three or more lines can also be provided for establishing a fluid-conducting connection between the drainage device and a vacuum source.
  • the drainage device can be assigned an occlusion film for producing a wound space containing the drainage device.
  • the drainage device can also be assigned additional open-pore drainage elements, such as a PU foam, a film, a film drainage system, a drainage tube or the like.
  • the drainage device can be designed so that it can be freely assembled by being designed to be cutable. In this way, drainage devices with the required shape can easily be produced by the surgeon, with the drainage properties being able to be achieved in the desired manner by positioning the multilayer composite structure.
  • the drainage device of a wound care arrangement can also be connected in a fluid-conducting manner to drainage tubes or other fluid-conducting drainages, via which rinsing liquids and / or medicaments can be supplied to the drainage device.
  • the drainage device can be used both to supply and to suck out liquids.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un système de traitement de plaies comprenant un dispositif de drainage pour évacuer des fluides d'un corps humain ou animal, en particulier depuis une plaie, le dispositif de drainage étant une structure composite multicouche ayant deux surfaces de délimitation se faisant face mutuellement, au moins partiellement perméables aux fluides, s'étendant en particulier approximativement parallèlement l'une à l'autre. Une première surface de délimitation extérieure d'une première couche de drainage, au moins partiellement opposée à une couche limite entre deux couches de drainage adjacentes, est réalisée avec une première constitution de surface, et l'autre surface de délimitation extérieure d'une seconde couche de drainage, au moins partiellement opposée à une couche limite entre deux couches de drainage adjacentes, est réalisée avec une seconde constitution de surface différente de la première constitution de surface, les couches de drainage étant de préférence reliées l'une à l'autre de manière à conduire les fluides.
PCT/EP2021/053202 2020-02-11 2021-02-10 Système de traitement de plaies WO2021160666A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP21705145.7A EP4103119A1 (fr) 2020-02-11 2021-02-10 Système de traitement de plaies

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE202020100710.6U DE202020100710U1 (de) 2020-02-11 2020-02-11 Wundbehandlungsanordnung
DE202020100710.6 2020-02-11

Publications (1)

Publication Number Publication Date
WO2021160666A1 true WO2021160666A1 (fr) 2021-08-19

Family

ID=74595284

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2021/053202 WO2021160666A1 (fr) 2020-02-11 2021-02-10 Système de traitement de plaies

Country Status (3)

Country Link
EP (1) EP4103119A1 (fr)
DE (1) DE202020100710U1 (fr)
WO (1) WO2021160666A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007051599A1 (fr) * 2005-11-02 2007-05-10 Birgit Riesinger Corps d'absorption destine a etre applique sur la surface cutanee d'un etre humain ou d'un animal
EP2567681A1 (fr) * 2011-09-09 2013-03-13 Paul Hartmann AG Pansement pour la zone abdominale
WO2014044400A1 (fr) * 2012-09-20 2014-03-27 Lohmann & Rauscher Gmbh Dispositif de traitement par pression négative et feuille pour la réalisation d'un dispositif de traitement par pression négative
DE202015000910U1 (de) * 2015-02-04 2015-03-02 Norbert Neubauer Drainagevorrichtung zur Wundbehandlung
DE102014216139A1 (de) * 2014-08-13 2016-02-18 Paul Hartmann Ag Wundverbandset zur Behandlung von Wundkavitäten
US20180353344A1 (en) * 2017-06-07 2018-12-13 Kci Licensing, Inc. Methods For Manufacturing And Assembling Dual Material Tissue Interface For Negative-Pressure Therapy

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102008061536A1 (de) * 2008-12-03 2010-06-10 Aesculap Ag Medizintechnischer Saugkörper, insbesondere zur Entfernung von Wundflüssigkeiten aus menschlichen und/oder tierischen Körperhöhlen
DE102009019646B4 (de) * 2009-04-30 2015-04-30 Lohmann & Rauscher Gmbh Wundabdeckung und Verfahren zum Herstellen
DE102010052336A1 (de) * 2010-11-25 2012-05-31 Paul Hartmann Ag Wundauflage für die Unterdrucktherapie

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007051599A1 (fr) * 2005-11-02 2007-05-10 Birgit Riesinger Corps d'absorption destine a etre applique sur la surface cutanee d'un etre humain ou d'un animal
EP2567681A1 (fr) * 2011-09-09 2013-03-13 Paul Hartmann AG Pansement pour la zone abdominale
WO2014044400A1 (fr) * 2012-09-20 2014-03-27 Lohmann & Rauscher Gmbh Dispositif de traitement par pression négative et feuille pour la réalisation d'un dispositif de traitement par pression négative
DE102014216139A1 (de) * 2014-08-13 2016-02-18 Paul Hartmann Ag Wundverbandset zur Behandlung von Wundkavitäten
DE202015000910U1 (de) * 2015-02-04 2015-03-02 Norbert Neubauer Drainagevorrichtung zur Wundbehandlung
US20180353344A1 (en) * 2017-06-07 2018-12-13 Kci Licensing, Inc. Methods For Manufacturing And Assembling Dual Material Tissue Interface For Negative-Pressure Therapy

Also Published As

Publication number Publication date
EP4103119A1 (fr) 2022-12-21
DE202020100710U1 (de) 2021-05-12

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